睡眠時間シフト後の一時的な不眠症に対するメラトニンアゴニストタシメルテオン (VEC-162) 2つのランダム化多センター試験
Shantha Mw Rajaratnam1, Mihael H Polymeropoulos, Dennis M Fisher
1Division of Sleep Medicine, Harvard Medical School, Boston, MA, USA.
Lancet (London, England)
|December 5, 2008
まとめ
タシメルテオンは,睡眠の開始と維持を改善することによって,一時的な不眠症を効果的に治療します. このメラトニンアゴニストはまた,昼夜リズムをシフトさせ,睡眠障害の管理に潜在力を提供します.
科学分野:
- スリープ・メディシン (睡眠医学)
- クロノバイオロジーはクロノバイオロジーを用います.
- 薬理学 薬理学とは
背景:
- シルカディアンリズム睡眠障害は,不眠症の重要な原因です.
- 暫定的な不眠症は,しばしば睡眠と覚醒の時間の変化によるものです.
- メラトニンアゴニストは,そのような睡眠障害の治療のために研究されています.
研究 の 目的:
- タシメルテオンの効果と生理学的メカニズムを第2相研究で確立する.
- 臨時不眠症に対するタシメルテオンの有効性をIII相研究で確認する.
主な方法:
- 2つのランダム化,ダブルブラインド,プラセボ対照試験 (第2期および第3期) が実施されました.
- 参加者は,異なる量のタシメルテオンまたはプラセボを受けた.
- 睡眠効率,睡眠遅延時間,および昼間周期は,主な有効性指標でした.
主要な成果:
- タシメルテオンは,睡眠の遅延を軽減し,両方の研究で睡眠効率を高めました.
- 血メラトニンリズムにおける用量依存のシフトが観察されました.
- 副作用の頻度は,タシメルテオン群とプラセボ群の間で比較可能でした.
結論:
- タシメルテオンは,睡眠時間の急激な前進の後,睡眠の開始と維持を改善しました.
- 薬は同時に内生的な昼夜リズムをシフトさせた.
- タシメルテオンは,昼夜リズム睡眠障害における一時的な不眠症の治療の可能性を示しています.
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